MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLATCUT TALAR DOME SZ 4 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Numbness (2415); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical study infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2): subject: (b)(6).As reported: "left ankle pain, swelling, and numbness.Patient was seen for 3 month follow up of left ankle on (b)(6) 2023 with complaints of pain, swelling, and numbness since last visit on (b)(6) 2023.Most of the pain was reported outside aspect of ankle.Examination showed well-healed scar with tenderness of left subtalar joint with minimal discomfort lateral aspect of the ankle.Radiographic imaging showed no evidence of lucency.Around the hardware.Patient is to continue wearing boot, physical therapy, use voltaren gel, and stabilize the ankle with prescribed lace-up ankle brace.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text: device disposition unknown.
Event or Problem Description
Clinical study infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2): subject (b)(6).As reported: "left ankle pain, swelling, and numbness patient was seen for 3 month follow up of left ankle on (b)(6) 2023 with complaints of pain, swelling, and numbness since last visit on (b)(6) 2023.Most of the pain was reported outside aspect of ankle.Examination showed well-healed scar with tenderness of left subtalar joint with minimal discomfort lateral aspect of the ankle.Radiographic imaging showed no evidence of lucency.Around the hardware.Patient is to continue wearing boot, physical therapy, use voltaren gel, and stabilize the ankle with prescribed lace-up ankle brace.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: FLATCUT TALAR DOME SZ 4 INFINITY ADAPTIS
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17864740
• Report Number: 3010667733-2023-00586
• Device Sequence Number: 14934979
• Product Code: HSN
• UDI-Device Identifier: 00889797073080
• UDI-Public: 00889797073080
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33680034
• Device Lot Number: 1739353
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 100 KG